| name | mdr-745-specialist |
| description | EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Annex VIII classification rules, Annex II/III technical files, Annex XIV clinical evaluation, and EUDAMED integration. |
MDR 2017/745 Specialist
EU MDR compliance patterns for medical device classification, technical documentation, and clinical evidence.
Table of Contents
Device Classification Workflow
Classify device under MDR Annex VIII:
- Identify device duration (transient, short-term, long-term)
- Determine invasiveness level (non-invasive, body orifice, surgical)
- Assess body system contact (CNS, cardiac, other)
- Check if active device (energy dependent)
- Apply classification rules 1-22
- For software, apply MDCG 2019-11 algorithm
- Document classification rationale
- Validation: Classification confirmed with Notified Body
Classification Matrix
| Factor | Class I | Class IIa | Class IIb | Class III |
|---|
| Duration | Any | Short-term | Long-term | Long-term |
| Invasiveness | Non-invasive | Body orifice | Surgical | Implantable |
| System | Any | Non-critical | Critical organs | CNS/cardiac |
| Risk | Lowest | Low-medium | Medium-high | Highest |
Software Classification (MDCG 2019-11)
| Information Use | Condition Severity | Class |
|---|
| Informs decision | Non-serious | IIa |
| Informs decision | Serious | IIb |
| Drives/treats | Critical | III |
Classification Examples
Example 1: Absorbable Surgical Suture
- Rule 8 (implantable, long-term)
- Duration: > 30 days (absorbed)
- Contact: General tissue
- Classification: Class IIb
Example 2: AI Diagnostic Software
- Rule 11 + MDCG 2019-11
- Function: Diagnoses serious condition
- Classification: Class IIb
Example 3: Cardiac Pacemaker
- Rule 8 (implantable)
- Contact: Central circulatory system
- Classification: Class III
Technical Documentation
Prepare technical file per Annex II and III:
- Create device description (variants, accessories, intended purpose)
- Develop labeling (Article 13 requirements, IFU)
- Document design and manufacturing process
- Complete GSPR compliance matrix
- Prepare benefit-risk analysis
- Compile verification and validation evidence
- Integrate risk management file (ISO 14971)
- Validation: Technical file reviewed for completeness
Technical File Structure
ANNEX II TECHNICAL DOCUMENTATION
├── Device description and UDI-DI
├── Label and instructions for use
├── Design and manufacturing info
├── GSPR compliance matrix
├── Benefit-risk analysis
├── Verification and validation
└── Clinical evaluation report
GSPR Compliance Checklist
| Requirement | Evidence | Status |
|---|
| Safe design (GSPR 1-3) | Risk management file | ☐ |
| Chemical properties (GSPR 10.1) | Biocompatibility report | ☐ |
| Infection risk (GSPR 10.2) | Sterilization validation | ☐ |
| Software requirements (GSPR 17) | IEC 62304 documentation | ☐ |
| Labeling (GSPR 23) | Label artwork, IFU | ☐ |
Conformity Assessment Routes
| Class | Route | NB Involvement |
|---|
| I | Annex II self-declaration | None |
| Is/Im | Annex II + IX/XI | Sterile/measuring aspects |
| IIa | Annex II + IX or XI | Product or QMS |
| IIb | Annex IX + X or X + XI | Type exam + production |
| III | Annex IX + X | Full QMS + type exam |
Clinical Evidence
Develop clinical evidence strategy per Annex XIV:
- Define clinical claims and endpoints
- Conduct systematic literature search
- Appraise clinical data quality
- Assess equivalence (technical, biological, clinical)
- Identify evidence gaps
- Determine if clinical investigation required
- Prepare Clinical Evaluation Report (CER)
- Validation: CER reviewed by qualified evaluator
Evidence Requirements by Class
| Class | Minimum Evidence | Investigation |
|---|
| I | Risk-benefit analysis | Not typically required |
| IIa | Literature + post-market | May be required |
| IIb | Systematic literature review | Often required |
| III | Comprehensive clinical data | Required (Article 61) |
Clinical Evaluation Report Structure
CER CONTENTS
├── Executive summary
├── Device scope and intended purpose
├── Clinical background (state of the art)
├── Literature search methodology
├── Data appraisal and analysis
├── Safety and performance conclusions
├── Benefit-risk determination
└── PMCF plan summary
Qualified Evaluator Requirements
- Medical degree or equivalent healthcare qualification
- 4+ years clinical experience in relevant field
- Training in clinical evaluation methodology
- Understanding of MDR requirements
Post-Market Surveillance
Establish PMS system per Chapter VII:
- Develop PMS plan (Article 84)
- Define data collection methods
- Establish complaint handling procedures
- Create vigilance reporting process
- Plan Periodic Safety Update Reports (PSUR)
- Integrate with PMCF activities
- Define trend analysis and signal detection
- Validation: PMS system audited annually
PMS System Components
| Component | Requirement | Frequency |
|---|
| PMS Plan | Article 84 | Maintain current |
| PSUR | Class IIa and higher | Per class schedule |
| PMCF Plan | Annex XIV Part B | Update with CER |
| PMCF Report | Annex XIV Part B | Annual (Class III) |
| Vigilance | Articles 87-92 | As events occur |
PSUR Schedule
| Class | Frequency |
|---|
| Class III | Annual |
| Class IIb implantable | Annual |
| Class IIb | Every 2 years |
| Class IIa | When necessary |
Serious Incident Reporting
| Timeline | Requirement |
|---|
| 2 days | Serious public health threat |
| 10 days | Death or serious deterioration |
| 15 days | Other serious incidents |
EUDAMED and UDI
Implement UDI system per Article 27:
- Obtain issuing entity code (GS1, HIBCC, ICCBBA)
- Assign UDI-DI to each device variant
- Assign UDI-PI (production identifier)
- Apply UDI carrier to labels (AIDC + HRI)
- Register actor in EUDAMED
- Register devices in EUDAMED
- Upload certificates when available
- Validation: UDI verified on sample labels
EUDAMED Modules
| Module | Content | Actor |
|---|
| Actor | Company registration | Manufacturer, AR |
| UDI/Device | Device and variant data | Manufacturer |
| Certificates | NB certificates | Notified Body |
| Clinical Investigation | Study registration | Sponsor |
| Vigilance | Incident reports | Manufacturer |
| Market Surveillance | Authority actions | Competent Authority |
UDI Label Requirements
Required elements per Article 13:
Reference Documentation
MDR Classification Guide
references/mdr-classification-guide.md contains:
- Complete Annex VIII classification rules (Rules 1-22)
- Software classification per MDCG 2019-11
- Worked classification examples
- Conformity assessment route selection
Clinical Evidence Requirements
references/clinical-evidence-requirements.md contains:
- Clinical evidence framework and hierarchy
- Literature search methodology
- Clinical Evaluation Report structure
- PMCF plan and evaluation report guidance
Technical Documentation Templates
references/technical-documentation-templates.md contains:
- Annex II and III content requirements
- Design History File structure
- GSPR compliance matrix template
- Declaration of Conformity template
- Notified Body submission checklist
Tools
MDR Gap Analyzer
python scripts/mdr_gap_analyzer.py --device "Device Name" --class IIa
python scripts/mdr_gap_analyzer.py --device "Device Name" --class III --output json
python scripts/mdr_gap_analyzer.py --interactive
Analyzes device against MDR requirements, identifies compliance gaps, generates prioritized recommendations.
Output includes:
- Requirements checklist by category
- Gap identification with priorities
- Critical gap highlighting
- Compliance roadmap recommendations
Notified Body Interface
Selection Criteria
| Factor | Considerations |
|---|
| Designation scope | Covers your device type |
| Capacity | Timeline for initial audit |
| Geographic reach | Markets you need to access |
| Technical expertise | Experience with your technology |
| Fee structure | Transparency, predictability |
Pre-Submission Checklist
